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Services to Medical Device Companies Worldwide:
Many medical device companies lack the experience or staffing in
regulatory affairs, quality systems, and validations needed for FDA/ISO
compliance. Services are offered at reasonable rates to assist
companies in ensuring the design, development, and manufacturing of
safe and effective medical devices for U.S. and international markets
Sample Consulting Projects:
On-Site Audit (China, Taiwan, Japan, Malaysia, Thailand,
Vietnam)
Quality System Audit can be performed by Native English,
Japanese and Chinese.
FDA Related Seminar/Classes (Presentation in Native
Languages)
510(k) / 510(k) Exempt
Quality Management System Improvements/Implementation
FDA/QSR/GMP & ISO 13485:2003 Compliance
Establishing De ...sign Control & Design History
Domestic/International Regulatory Strategy
English/Japanese/Chinese Medical Device Translations
Company Registrations & Product Listings
Medical & Laser Product Regulatory Submissions
Software Validations (Product/Design/Process/Quality)
Hardware Validations (Fixture/Test/Process/Packaging)
Product Validations (Performance/Sterility/Aging/Shipping)
Training (GMP/Quality Systems/ISO/Validation) Read more
Many medical device companies lack the experience or staffing in
regulatory affairs, quality systems, and validations needed for FDA/ISO
compliance. Services are offered at reasonable rates to assist
companies in ensuring the design, development, and manufacturing of
safe and effective medical devices for U.S. and international markets
Sample Consulting Projects:
On-Site Audit (China, Taiwan, Japan, Malaysia, Thailand,
Vietnam)
Quality System Audit can be performed by Native English,
Japanese and Chinese.
FDA Related Seminar/Classes (Presentation in Native
Languages)
510(k) / 510(k) Exempt
Quality Management System Improvements/Implementation
FDA/QSR/GMP & ISO 13485:2003 Compliance
Establishing De ...sign Control & Design History
Domestic/International Regulatory Strategy
English/Japanese/Chinese Medical Device Translations
Company Registrations & Product Listings
Medical & Laser Product Regulatory Submissions
Software Validations (Product/Design/Process/Quality)
Hardware Validations (Fixture/Test/Process/Packaging)
Product Validations (Performance/Sterility/Aging/Shipping)
Training (GMP/Quality Systems/ISO/Validation) Read more
Other Products
- Medical Product Consulting